Advertisement

Obesity Surgery

, Volume 28, Issue 7, pp 1812–1821 | Cite as

Endoscopic Sleeve Gastroplasty (ESG) Is a Reproducible and Effective Endoscopic Bariatric Therapy Suitable for Widespread Clinical Adoption: a Large, International Multicenter Study

  • Adrian Sartoretto
  • Zhixian Sui
  • Christine Hill
  • Margo Dunlap
  • Angielyn R. Rivera
  • Mouen A. Khashab
  • Anthony N. Kalloo
  • Lea Fayad
  • Lawrence J. Cheskin
  • George Marinos
  • Erik Wilson
  • Vivek Kumbhari
Original Contributions

Abstract

Objective

Endoscopic sleeve gastroplasty (ESG), an incisionless endoscopic bariatric procedure, has shown impressive results in case series. This study examines the reproducibility, efficacy, and safety in three centers across two countries, and identifies key determinants for procedural success.

Design

Patients who underwent ESG between February 2016 and May 2017 at one of three centers (Australia and USA) were retrospectively analyzed. All procedures were performed on an outpatient basis using the Apollo OverStitch device (Apollo Endosurgery, Austin, TX). Primary outcomes included absolute weight loss (ΔWeight, kg), change in body mass index (∆BMI, in kg/m2), total body weight loss (TBWL, %), excess weight loss (EWL, in %), and immediate and delayed adverse events.

Results

In total, 112 consecutive patients (male 31%, age 45.1 ± 11.7 years, baseline BMI 37.9 ± 6.7 kg/m2) underwent ESG. At 1, 3, and 6 months, Δweight was 9.0 ± 4.6 kg (TBWL 8.4 ± 4.1%), 12.9 ± 6.4 kg (TBWL 11.9 ± 4.5%), and 16.4 ± 10.7 kg (TBWL 14.9 ± 6.1%), respectively. The proportion of patients who attained greater than 10% TBWL and 25% EWL was 62.2 and 78.0% at 3 months post-ESG and 81.0 and 86.5% at 6 months post-ESG. Weight loss was similar between the three centers. Multivariable analysis showed that male sex, greater baseline body weight, and lack of prior endoscopic bariatric therapy were predictors of greater Δweight at 6 months. Three (2.7%) severe adverse events were observed.

Conclusions

ESG is an effective, reproducible, and safe weight loss therapy that is suitable for widespread clinical adoption.

Keywords

Endoscopic sleeve gastroplasty Weight loss Obesity Endoscopic bariatric therapy Endoscopic suturing 

Abbreviations

APC

argon plasma coagulation

EBT

endoscopic bariatric therapy

ESG

endoscopic sleeve gastroplasty

EW

excess weight

EWL

excess weight loss

ORCD

obesity-related chronic disease/condition

TBWL

total body weight loss

Notes

Authors’ Contributions

AS and VK had the concept of the work. AS, VK, and ZS completed data analysis and interpretation. All the authors had equal contributions in data collection, drafting the article, and critical revision of the article. All authors approved the final version of the article for publication.

Funding

No funding declaration is needed by the authors.

Compliance with Ethical Standards

Conflicts of Interest

AS, EW, and VK are consultants with Apollo Endosurgery. AS and GM are consultants for BAROnova. VK is also a consultant for Boston Scientific, Reshape Medical, and Medtronic. MAK is a consultant for Boston Scientific and Olympus America. ANK is a founding member, equity holder, and consultant for Apollo Endosurgery. EW is a consultant for Gore, Intuitive, Ethicon, Olympus, and EndoGastric Solutions. The remaining authors disclose no conflict of interest.

Ethics Statement

All procedures performed in the study were in accordance with the ethical standards of the institutional committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. For this type of retrospective study, formal consent is not required.

Consent Statement

Informed consent was obtained from all individual participants included in the study.

Supplementary material

11695_2018_3135_MOESM1_ESM.docx (648 kb)
ESM 1 (DOCX 647 kb).

References

  1. 1.
    Bray GA, Kim KK, Wilding JPH, World obesity F. Obesity: a chronic relapsing progressive disease process. A position statement of the world obesity federation. Obesity reviews : an official journal of the International Association for the Study of Obesity 2017 Jul;18(7):715–723. PubMed, DOI:  https://doi.org/10.1111/obr.12551
  2. 2.
    Welbourn R, Pournaras DJ, Dixon J, Higa K, Kinsman R, Ottosson J, et al. Bariatric surgery worldwide: baseline demographic description and one-year outcomes from the second IFSO Global Registry Report 2013-2015. Obes Surg 2017 Aug 18. PubMedGoogle Scholar
  3. 3.
    Wharton S, Serodio KJ, Kuk JL, Sivapalan N, Craik A, Aarts MA. Interest, views and perceived barriers to bariatric surgery in patients with morbid obesity. Clin Obes 2016 Apr;6(2):154–160. PubMed, DOI:  https://doi.org/10.1111/cob.12131
  4. 4.
    Force ABET, Committee AT, Abu Dayyeh BK, Kumar N, Edmundowicz SA, Jonnalagadda S, et al. ASGE bariatric endoscopy task force systematic review and meta-analysis assessing the ASGE PIVI thresholds for adopting endoscopic bariatric therapies. Gastrointest Endosc 2015 Sep;82(3):425–438 e5. PubMedGoogle Scholar
  5. 5.
    Abu Dayyeh BK, Edmundowicz S, Thompson CC. Clinical practice update: expert review on endoscopic bariatric therapies. Gastroenterology 2017 Mar;152(4):716–729. PubMed, DOI:  https://doi.org/10.1053/j.gastro.2017.01.035
  6. 6.
    Bazerbachi F, Vargas Valls EJ, Abu Dayyeh BK. Recent clinical results of endoscopic bariatric therapies as an obesity intervention. Clin Endosc 2017 Jan;50(1):42–50. PubMed Pubmed Central PMCID: PMC5299988, DOI:  https://doi.org/10.5946/ce.2017.013.
  7. 7.
    Kumbhari V, Hill C, Sullivan S. Bariatric endoscopy: state-of-the-art. Curr Opin Gastroenterol 2017 Sep;33(5):358–365. PubMed, DOI:  https://doi.org/10.1097/MOG.0000000000000383
  8. 8.
    Hill C, Khashab MA, Kalloo AN, Kumbhari V. Endoluminal weight loss and metabolic therapies: current and future techniques. Ann N Y Acad Sci 2017 Sep 08. PubMedGoogle Scholar
  9. 9.
    Totte E, Hendrickx L, Pauwels M, Van Hee R. Weight reduction by means of intragastric device: experience with the bioenterics intragastric balloon. Obes Surg 2001 Aug;11(4):519–523. PubMedGoogle Scholar
  10. 10.
    Rohde U, Hedback N, Gluud LL, Vilsboll T, Knop FK. Effect of the EndoBarrier gastrointestinal liner on obesity and type 2 diabetes: a systematic review and meta-analysis. Diabetes Obes Metab 2016 Mar;18(3):300–305. PubMed, DOI:  https://doi.org/10.1111/dom.12603
  11. 11.
    Yorke E, Switzer NJ, Reso A, Shi X, de Gara C, Birch D, Gill R, Karmali S Intragastric balloon for management of severe obesity: a systematic review. Obes Surg 2016 Sep;26(9):2248–2254. PubMed, DOI:  https://doi.org/10.1007/s11695-016-2307-9
  12. 12.
    Badurdeen DS, Kumbhari V. Endoscopic sleeve gastroplasty and its application to China. J Dig Dis 2017 Sep 27. PubMedGoogle Scholar
  13. 13.
    Abu Dayyeh BK, Rajan E, Gostout CJ. Endoscopic sleeve gastroplasty: a potential endoscopic alternative to surgical sleeve gastrectomy for treatment of obesity. Gastrointest Endosc 2013 Sep;78(3):530–535. PubMed, DOI:  https://doi.org/10.1016/j.gie.2013.04.197
  14. 14.
    Saumoy M, Schneider Y, Zhou XK, Shukla A, Kahaleh M, Aronne L, et al. A single-operator learning curve analysis for the endoscopic sleeve gastroplasty. Gastrointest Endosc 2017 Aug 24. PubMedGoogle Scholar
  15. 15.
    Lopez-Nava G, Galvao MP, Bautista-Castano I, Jimenez-Banos A, Fernandez-Corbelle JP. Endoscopic sleeve gastroplasty: how I do it? Obes Surg 2015 Aug;25(8):1534–1538. PubMed, DOI:  https://doi.org/10.1007/s11695-015-1714-7
  16. 16.
    Abu Dayyeh BK, Acosta A, Camilleri M, Mundi MS, Rajan E, Topazian MD, Gostout CJ Endoscopic sleeve Gastroplasty alters gastric physiology and induces loss of body weight in obese individuals. Clin Gastroenterol Hepatol 2017 Jan;15(1):37–43 e1. PubMed, DOI:  https://doi.org/10.1016/j.cgh.2015.12.030
  17. 17.
    Sharaiha RZ, Kumta NA, Saumoy M, Desai AP, Sarkisian AM, Benevenuto A, Tyberg A, Kumar R, Igel L, Verna EC, Schwartz R, Frissora C, Shukla A, Aronne LJ, Kahaleh M Endoscopic sleeve gastroplasty significantly reduces body mass index and metabolic complications in obese patients. Clin Gastroenterol Hepatol 2017 Apr;15(4):504–510. PubMed, DOI:  https://doi.org/10.1016/j.cgh.2016.12.012
  18. 18.
    Lopez-Nava G, Galvao MP, Bautista-Castano I, Fernandez-Corbelle JP, Trell M, Lopez N. Endoscopic sleeve Gastroplasty for obesity treatment: two years of experience. Arq Bras Cir Dig 2017 Jan-Mar;30(1):18–20. PubMed Pubmed Central PMCID: PMC5424680, DOI:  https://doi.org/10.1590/0102-6720201700010006.
  19. 19.
    Lopez-Nava G, Sharaiha RZ, Vargas EJ, Bazerbachi F, Manoel GN, Bautista-Castano I, et al. Endoscopic sleeve gastroplasty for obesity: a multicenter study of 248 patients with 24 months follow-up. Obes Surg 2017 Apr 27. PubMed, 10, 2649, 2655, DOI:  https://doi.org/10.1007/s11695-017-2693-7
  20. 20.
    Lopez-Nava G, Galvao MP, da Bautista-Castano I, Jimenez A, De Grado T, Fernandez-Corbelle JP. Endoscopic sleeve gastroplasty for the treatment of obesity. Endoscopy 2015 May;47(5):449–452. PubMed, DOI:  https://doi.org/10.1055/s-0034-1390766
  21. 21.
    Hill C, El Zein M, Agnihotri A, Dunlap M, Chang A, Agrawal A, Barola S, Ngamruengphong S, Chen YI, Kalloo AN, Khashab MA, Kumbhari V Endoscopic sleeve gastroplasty: the learning curve. Endosc Int Open 2017 Sep;5(9):E900-E9E4. PubMed Pubmed Central PMCID: PMC5597932, DOI:  https://doi.org/10.1055/s-0043-115387.
  22. 22.
    Barola S, Chen YI, Ngamruengphong S, Kalloo AN, Khashab MA, Kumbhari V. Technical aspects of endoscopic sleeve gastroplasty. Gastrointest Endosc 2017 Apr;85(4):862. PubMed, DOI:  https://doi.org/10.1016/j.gie.2017.02.012
  23. 23.
    Barola S, Agnihotri A, Khashab MA, Kumbhari V. Perigastric fluid collection after endoscopic sleeve gastroplasty. Endoscopy. 2016 0;48(S 01):E340-E1. PubMedGoogle Scholar
  24. 24.
    Moura D, Oliveira J, De Moura EG, Bernardo W, Galvao Neto M, Campos J, et al. Effectiveness of intragastric balloon for obesity: a systematic review and meta-analysis based on randomized control trials. Surg Obes Relat Dis 2016 Feb;12(2):420–429. PubMed, DOI:  https://doi.org/10.1016/j.soard.2015.10.077
  25. 25.
    Imaz I, Martinez-Cervell C, Garcia-Alvarez EE, Sendra-Gutierrez JM, Gonzalez-Enriquez J. Safety and effectiveness of the intragastric balloon for obesity. A meta-analysis. Obes Surg 2008 Jul;18(7):841–846. PubMed, DOI:  https://doi.org/10.1007/s11695-007-9331-8
  26. 26.
    Gaur S, Levy S, Mathus-Vliegen L, Chuttani R. Balancing risk and reward: a critical review of the intragastric balloon for weight loss. Gastrointest Endosc 2015;81(6):1330–1336. PubMed, DOI:  https://doi.org/10.1016/j.gie.2015.01.054
  27. 27.
    Kim SH, Chun HJ, Choi HS, Kim ES, Keum B, Jeen YT. Current status of intragastric balloon for obesity treatment. World J Gastroenterol 2016 Jun 28;22(24):5495–5504. PubMed Pubmed Central PMCID: PMC4917609, DOI:  https://doi.org/10.3748/wjg.v22.i24.5495.
  28. 28.
    Therapy AATFoEB, Ginsberg GG, Chand B, Cote GA, Dallal RM, Edmundowicz SA, et al. A pathway to endoscopic bariatric therapies. Gastrointest Endosc 2011 Nov;74(5):943–953. PubMedGoogle Scholar
  29. 29.
    Inge TH, Jenkins TM, Zeller M, et al. Baseline BMI is a strong predictor of nadir BMI after adolescent gastric bypass. J Pediatr. 2010 Jan;156(1):103–8 e1. PubMed Pubmed Central PMCID: PMC2886665.  https://doi.org/10.1016/j.jpeds.2009.07.028.
  30. 30.
    Diniz Mde F, Passos VM, Barreto SM, Linares DB, de Almeida SR, Rocha AL, et al. Different criteria for assessment of roux-en-Y gastric bypass success: does only weight matter? Obes Surg 2009 Oct;19(10):1384–1392. PubMed, DOI:  https://doi.org/10.1007/s11695-008-9669-6

Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2018

Authors and Affiliations

  • Adrian Sartoretto
    • 1
  • Zhixian Sui
    • 1
  • Christine Hill
    • 2
  • Margo Dunlap
    • 3
  • Angielyn R. Rivera
    • 4
  • Mouen A. Khashab
    • 3
  • Anthony N. Kalloo
    • 3
  • Lea Fayad
    • 3
  • Lawrence J. Cheskin
    • 2
    • 3
  • George Marinos
    • 1
  • Erik Wilson
    • 4
  • Vivek Kumbhari
    • 3
  1. 1.Bariatric and Metabolic InstituteDouble BayAustralia
  2. 2.Johns Hopkins Weight Management Center, Department of Health, Behavior & SocietyJohns Hopkins Bloomberg School of Public HealthBaltimoreUSA
  3. 3.Division of Gastroenterology and Hepatology, Department of MedicineThe Johns Hopkins Medical InstitutionsBaltimoreUSA
  4. 4.Department of SurgeryThe University of Texas Health Science Center at HoustonHoustonUSA

Personalised recommendations